Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations

Not Applicable

Completed

• Conditions: Amputation; Traumatic, Leg, Lower; Amputation
• Interventions: Device: WRL TTP

• Registration Number: NCT06161961
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief Summary

The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-tibial amputees.

The main question it aims to answer are:

* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.

* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.

Participants will perform:

* walking tests inside parallel bars on flat and/or inclined terrain;

* walking tests on treadmill;

* stair climbing/descent tests.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-21
• Primary Completion: 2022-11-10
• Study Completion: 2022-12-22
• Status Verified: 2023-11
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Trans-tibial lower limb amputation;
• Medicare functional classification: Level K3-K4;
• Subjects who have worn prostheses for at least 1 year (experienced wearers);
• Use of prosthesis with energy-returning prosthetic foot.

Exclusion Criteria

• Relevant medical comorbidities (serious neurological pathologies, cardiovascular pathologies, diabetes/hypertension not stabilized, severe sensory deficits);
• Wearers of implantable cardiac medical devices (PMK or AICD);
• Cognitive impairment (MMSE corrected for age and education <24);
• Inability or unavailability to provide informed consent;
• Severe depressive and/or anxious symptoms.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prosthetic group	WRL TTP	prosthetic group performs the entire protocol with the prosthesis prototype.

Primary Outcome Measures

Name	Time	Method
ad hoc check-list Adverse Event	day 5	questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.

Secondary Outcome Measures

Name	Time	Method
TUG - Timed Up and GO	day 3	to assess lower limb capability
CR-10 Borg Scale	day 5	0-10 numerical rating scale that evaluate of the subjective perception of effort during walking
System usability scale	day 5	a questionnaire made up of 10 questions whose answers are yes structured on a Likert scale with values 0-100 that assess the usability of the prosthesis
10mwt - 10 meters walking test	day 3	to assess the walking speed
SCT - stair climb test	day 3	to assess the capability of climb 8 stairs
Gait analisys	day 5	to assess the gait pattern
6mwt - 6 minute walking test on the treadmill	day 5	to assess the fatigue

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi; 🇮🇹 Firenze, FI, Italy